Venture-backed ophthalmology implant company AcuFocus is going before an FDA committee on June 6. The agency's ophthalmic devices panel will consider the company's Kamra inlay, a surgical intracorneal implant that is under review to improve near and intermediate vision.
Kamra is specifically for presbyopic patients whose eyes have lost flexibility over time, which results in near vision loss that typically starts to become noticeable in the early to mid-40s. There's no device available for these patients. Refractive surgery like Lasik is an option, but it often can worsen vision for presbyopic patients, according to the Mayo Clinic.
The inlay is a relatively known quantity--it's approved in 50 countries and launched in 33 of those. More than 20,000 inlays have been implanted in patients outside of the U.S. In the postmarketing experience, 362 of these inlays have been removed. Most of these were due to vision complaints including distance and near vision. Kamra was launched in Japan in 2009 and in Europe in 2010.
In the pivotal data presented to the FDA committee, Kamra met the primary endpoint of 75% of eyes achieving uncorrected near visual acuity of 20/40 or better. In the study, 396 out of 474 eyes with the inlay (83.5%) had near visual acuity of 20/40 or better after 12 months. A total of 44 inlays (8.7%) were removed during the course of the study, mostly due to vision complaints.
AcuFocus has a heavyweight lineup of investors awaiting the outcome of this FDA panel. Its last disclosed financing was a $65 million financing, which included $40 million in equity and $25 million in a "synthetic royalty" that takes a share of future sales. Cowen Healthcare Royalty Partners did the royalty portion and contributed $5 million to lead the venture round. Existing investors SV Life Sciences, Versant Ventures, Carlyle Group, Accuitive Medical Ventures and Bausch & Lomb also participated.
The company hasn't disclosed sales figures for the Kamra inlay, which is designed to create a small aperture effect that enhances near and intermediate objects while maintaining distance vision.
- here are the panel docs and agenda